Two US state agencies have acknowledged of inaccurate HIV tests in Kenya and several African countries.
Kemri, in a study funded by BioLytical® Laboratories Inc., of Canada, manufacturers of INSTI HIV test, praised the kit for its high performance and recommended it for self-testing.
“The excellent performance and usability characteristics of INSTI HIV-1/HIV-2 self-test make the kit a viable option for HIV self-testing,” says the study published on Thursday in the journal Plos One.
Though a coincidence, the praise comes days after the United States Agency for International Development (USAID) and the Centers for Disease Control and Prevention, (CDC), has acknowledged to inaccuracies but downplayed their significance.
The US agencies were reacting to reports by MSF showing dominant HIV kits used in Kenya and four other African countries had failed crucial quality tests.
In a detailed rejoinder published two weeks ago the US says it has reanalyzed the data against its own in the mentioned project areas and concluded the inaccuracies are not significant.
“Our modeling of the MSF data does show some variation in diagnostic accuracy of algorithms, but we found only a very small population level effect,” said DrAmy Kravitz Del Solar of USAID and lead author of the US observation.
The MSF report which had caused a stir in the global health community last year said seven of eight dominant HIV Rapid Diagnostic Tests (RDTs) had failed to meet crucial World Health Organisation (WHO) threshold.
The study had said the kits used in Kenya, Guinea, Uganda, Cameroon, and the Democratic Republic of the Congo had failed the tests despite having been certified by the WHO.
“Most kits performed more poorly than in WHO evaluations, with only one test (STAT-PAK) meeting the recommended thresholds,” lead author Cara S. Kosack of MSF had told this writer.
MSF had undertaken the evaluation after finding cases of HIV misdiagnosis in their programmes in the five countries; areas where US agencies also support Aids projects.
The evaluation was also carried out at a time the WHO and partners had cited increasing cases of HIV misdiagnosis, reaching up to 10.5 per cent in some African countries.
“The US President’s Emergency Plan for AIDS Relief (PEPFAR) works in five of the sites analysed in the MSF study,” says the US response published in the Journal of the International AIDS Society.
“The evaluation shows some variation in diagnostic accuracy of the kits (algorithms), but this has only a very small population-level effect,” the Americans have concluded.
The US has confirmed HIV misdiagnosis in Africa, as reported earlier by Médecins sans Frontières (MSF) but on Thursday the Kenya Medical Research Institute was all praise for one of the kits.
Though playing down the magnitude of inaccuracies, the Americans however acknowledged that the consequences of any HIV misdiagnoses ‘are serious, to affected individuals and health systems.’
Both MSF and US seem to agree over occurrence of inaccuracies but differ on the cause. MSF largely blames the technology while the US puts the blame mainly on human errors and biological and geographical factors.
While a representative of the Africa Union from Addis Ababa was involved in the US analysis, none of the five African governments has ever publicly responded to the MSF findings.
Our efforts to get a response from the Kenya’s Director of Medical Services Dr Jackson Kioko went answered. But last year Dr Kioko defended the kits, saying that due process was followed in their acquisition.
“Let me clearly state that all health products in this country are duly evaluated and registered before they are adopted in the national diagnostic and treatment protocols,” he said.
Meanwhile the Americans say while it may not be possible to eliminate all inaccuracies they can be reduced.
“PEPFAR recommends that all countries use WHO pre-qualified RDTs within the recommended strategies and directions for HIV testing.”
It also wants countries using such kits to have them evaluated domestically because performance may vary depending on geographical and population differences.
Most importantly the US says no patient should be put on antiretroviral medication before being retested for confirmation.
“We support verification retesting for all people with an HIV-positive diagnosis prior to starting on ART, as a critical quality assurance that those starting on medication are indeed HIV positive.”
Since the MSF study, the situation has changed in Kenya with the government having introduced self-testing HIV kits.
Last month the National Aids and STIs Control Programme (Nascop) had raised alarm over the high number of self-test kits sold in the local market without government certification.
Head of testing at NASCOP Mary Mugambi had told the local media this had raised serious concerns in the health sector.
“A wrongly done or interpreted test could lead to false results which could be disastrous for individuals and the self-testing project,” said Mugambi.
By Gatonye Gathura
MSF Study covered 8 brands of test kits
Brand Name Country of Manufacture
SD Bioline Korea
STAT-PAK US – Only kit which passed test
First Response India
Genie Fast France